Impact of Digital Communication Assist Tools in Endoscopic Team Communication During COVID-19

Not Applicable

• Conditions: Endoscopy; Communication
• Interventions: Other: DECT

• Registration Number: NCT04680858
• Lead Sponsor: University of Ulm

Brief Summary

Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly.Objective of the study is to evalaute the impact of digital enhanced telecommunication in endoscopic procedures.

Detailed Description

Optimal communication is crucial for team work in high class endoscopy. Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly. Digital enhanced approaches to maintain team communication during endoscopic procedures are mandatory not only in actual circumstances.

Materials and methods:A prospective, two-armed interventional study will be performed at an endoscopy unit at a tertiary center. 200 endoscopic examinations (EGD, colonoscopy, EUS, ERCP) were randomly assigned (1:1) to a group that was performed with DECT equipped endoscopy team or with standard communication. All examinations were performed under protective equipment. Primary outcome was rate of communication associated adverse events. Secondary outcomes included team subjectively perceived comfort with DECT enhanced communication during endoscopic work, duration of examinations, SAE.

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-17
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-23
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-31
• Primary Completion: 2021-01-31
• Study Completion: 2021-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Member of staff of the endoscopic team (Doctor, nurse)

Exclusion Criteria

• Deafness
• significantly impaired hearing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DECT enhanced Communication	DECT	Endoscopic procedures performed by skilled endoscopic team with enhanced communication tools ( DECT headset)

Primary Outcome Measures

Name	Time	Method
Communication associated adverse events	From start to stop of endoscopic procedure	Adverse events arising from impaired communication by COVID-19 protection equipment

Secondary Outcome Measures

Name	Time	Method
Subjective Comfort of DECT communication	From start to stop of endoscopic procedure	Subjectiveley perceived level of comfort using DECT communication during endoscopic procedures rated by numeric rating scale (1-6)
Endoscopic time	From start to stop of endoscopic procedure	Duration of performed endoscopic procedures
Severe adverse events	From start to stop of endoscopic procedure	Severe adverse evatent, not arising from from impaired communication by COVID-19 protection equipment

Trial Locations

Locations (1)

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany